Questions and Answers on Final Rule for Labeling Changes to Over-the-Counter Pain Relievers

The Food and Drug Administration (FDA) today finalized a regulation which requires that the labeling for over-the-counter (OTC) Internal Analgesic, Antipyretic and Antirheumatic (IAAA) drug products contain important new safety information. These OTC IAAA products include nonsteroidal anti-inflammatory drugs (NSAIDs) and acetaminophen. Consumers use these products to treat pain, fever, headaches, and muscle aches.

The regulation requires that the labeling of NSAIDs, such as aspirin, ibuprofen, naproxen and ketoprofen, contain important warnings regarding the potential for stomach bleeding. In addition, new warnings are required for labeling of acetaminophen about potential liver damage and when to consult a doctor.

FDA proposed labeling changes for IAAA drug products on December 26, 2006. In today's final rule, FDA is requiring the labeling changes proposed in the 2006 proposed rule as well as additional labeling suggested by comments received from the public in response to the 2006 proposed rule.

2. What specific labeling changes is FDA requiring for acetaminophen?

FDA is requiring

that the ingredient acetaminophen is prominently identified on the product’s principal display panel (PDP) of the immediate container, and the outer carton (if applicable). This is intended to help consumers identify the active ingredient and reduce the number of consumers inadvertently exposed to multiple products containing acetaminophen.

that the product label contain new warnings that highlight the potential for liver toxicity and warn consumers against using more than the recommended dose of acetaminophen; using more than one product (over-the-counter or prescription) containing with acetaminophen, and taking acetaminophen with moderate amounts of alcohol.

that the product label contain a warning not to use acetaminophen with any other drug containing acetaminophen and to ask a doctor or pharmacist if persons are not sure whether a drug contains acetaminophen, a warning to ask a doctor before use if persons have liver disease, and a warning to ask a doctor or pharmacist before use if persons are taking the blood thinning drug warfarin.

that the statement "see new warnings information" appears on the product's PDP for one year after the final rule is published.

3. What specific labeling changes is FDA requiring for NSAIDs?

FDA is requiring

that the term “NSAID” is prominently identified on the product’s principal display panel (PDP) of the immediate container and the outer carton (if applicable). This is intended to help consumers identify that the active ingredient of the product is an NSAID ingredient.

that the product label contain a new "Stomach bleeding warning" which highlights the potential for stomach bleeding in persons over age 60, in persons who have had prior ulcers or bleeding, in persons who take a blood thinner, when taking more than one product containing an NSAID, when taken with moderate amounts of alcohol, and when taking for longer time than directed.

that the product label contain warnings to ask a doctor before use if persons are at increased risk for stomach bleeding problems (which are listed on the label to assist consumers in identifying if they are at risk), and to stop use and ask a doctor if specific signs of stomach bleeding occur (which are listed on the label to assist consumers in identifying symptoms of stomach bleeding).

that the statement "see new warnings information" appears on the product's PDP for one year after the final rule is published.

4. How is this final rule different than the 2006 proposed rule for NSAID and acetaminophen products?

We are requiring much of the labeling included in the 2006 proposed rule, but are also requiring the following labeling that was not included in the 2006 proposed rule:

Liver warning and stomach bleeding warnings are required on immediate container labels in addition to the carton or outer container

Revised the first bullet of the liver warning from “more than [insert maximum number of daily dosage units] in 24 hours” to “more than [insert maximum number of daily dosage units] in 24 hours, which is the maximum daily amount”

Revised warning about using multiple products containing acetaminophen to clarify that consumers should ask a doctor or pharmacist if they are unsure whether a drug contains acetaminophen

New warning about taking warfarin and acetaminophen at the same time

Revised directions statement for all OTC IAAA drug products labeling for children under 12 years of age from “This product does not contain directions or warnings for adult use” to “This product does not contain directions or complete warnings for adult use”

Revised the stomach bleeding warning to indicate that the stomach bleeding can be severe

Revised NSIAD warning “ask a doctor if you have liver disease” to “ask a doctor if you have liver cirrhosis”

“NSAID” needs to be highlighted on the principal display panel, but the name of the active ingredient, such as ibuprofen, does not need to be highlighted.

In addition, we are allowing voluntary highlighting of information under the “Active Ingredient” and “Purpose” headings in Drug Facts for all OTC IAAA drug products.

5. What products does this regulation affect?

The new labeling is required for all OTC drug products that contain an NSAID or acetaminophen even if combined with other active ingredients, such as cold symptom relievers. This regulation is applicable only to OTC drug products and not to prescription products that NSAIDs or acetaminophen. Consumers may also be taking an NSAID or acetaminophen in their prescription medications, so it is important that they know the contents of both their prescription and OTC medications.

6. Are NSAID and acetaminophen products safe to use?

NSAID and acetaminophen drug products have been available for many years without a prescription to treat pain, fever, headaches and muscle aches. These products are safe and effective when properly used by consumers. FDA believes that consumers need to know that these products can cause serious side effects, such as severe liver injury and stomach bleeding, when used improperly. FDA urges consumers to read the labels of all the OTC medicines they take to use the medicines properly.

7. When can consumers expect to see these labeling changes on marketed NSAID and acetaminophen products?

A number of manufacturers already have voluntarily implemented labeling changes to identify these potential safety concerns. All OTC manufacturers of NSAID and acetaminophen products must comply with these labeling requirements by April 29, 2010.

8.Is FDA taking other steps to help ensure that acetaminophen and NSAIDs are used safely?

The Food and Drug Administration (FDA) will convene a public advisory committee meeting to be held on June 29 and June 30, 2009 regarding acetaminophen use in both over-the-counter (OTC) and prescription (Rx) products, the potential for liver injury, and potential interventions to reduce the incidence of liver injury.